NCT03648359

Brief Summary

To investigate whether multiparametric MRI (mp-MRI) in patients with low-risk prostate cancer can improve the selection of patients suitable for Active Surveillance and have a relevance in the ongoing monitoring

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2016

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
1.7 years until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

5.7 years

First QC Date

January 19, 2016

Last Update Submit

September 8, 2025

Conditions

Prostatic Neoplasms

Keywords

Prostate biopsyProstate cancerMagnetic resonance imagingNeoplasm staging

Outcome Measures

Primary Outcomes (1)

  • Changes in treatment from active surveillance (observation) to active treatment based on mp-MRI results.

    Patients enrolled in active surveillance will progress to active treatment if mp-MRI show previously undetected suspicious areas of significant disease. Significant cancer (measured by Gleason score and cancer core involvement on biopsies) will be confirmed by repeat biopsies of the suspicious areas. The decision to progress to active treatment is based on decision from the treating urologist.

    12 months

Study Arms (1)

Enrolled AS patients

OTHER

Patients with prostate cancer enrolled i active surveillance protocol using PSA, digital rectal examination and conventional TRUS-biopsies

Procedure: multiparametric MRI Diagnostics

Interventions

multiparametric MRI DiagnosticsPROCEDURE

Patients with newly diagnosed prostate cancer enrolled in active surveillance following standard protocol including PSA, DRE and TRUS biopsies and intervention with multiparametric MRI + additional biopsies if suspicious lesions are found

Enrolled AS patients

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with low risk localized prostate cancer enrolled in active surveillance

You may not qualify if:

  • Metastatic prostate cancer
  • No mp-MRI data present
  • Prostate cancer treatment
  • Known allergic reaction to Gadolinium-based MRI contrast agent
  • Prostate biopsy during the last 21 days
  • Impaired renal function with GFR \< 30 ml / min
  • pacemaker
  • Magnetic metal residues in the body
  • Claustrophobia
  • Psychiatric disorders
  • Age under 18 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Herlev University Hospital Herlev

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Lars Boesen, MD, PhD

    Department of Urology, Herlev University Hospital Herleb, Herlev, Denmark, 2730

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary investigator, MD, PhD

Study Record Dates

First Submitted

January 19, 2016

First Posted

August 27, 2018

Study Start

May 1, 2020

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations

DK(1)